BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

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    NEXAN SYSTEM, MODEL NX-300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Procure

    FDA UDI
    Twin Med, LLC·10840330700693·Trach Tie Small, Foam w/moisture repellent back...

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085024028·0.9% Saline 4.5ml

    Minit®

    FDA UDI
    ZIMMER SPINE, INC.·00889024333413·

    Harvest Esthetic DCL Denture

    FDA UDI
    Harvest Dental Products, LLC·D87010035201·CAD Tooth Polymer, Gradient - BL-3 98x20mm

    NorthStar

    FDA UDI
    Seaspine Orthopedics Corporation·10889981195984·Poly. Screw, 3.5mm x 20mm

    ALPHA OMEGA DUAL COOLER-HEATER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    C-IT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HAND PIECE FOR BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·April 9, 2015

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    FDA Adverse Event
    Malfunction ·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·February 11, 2013

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORP.·Product code LZG·February 20, 2011

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Other ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·February 19, 2008

    RUSCH 2W 10ML 100% SILICONE STR H 20

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL SDN. BHD.·Product code EZL·May 19, 2023

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·October 29, 2014